Starting in 1979 as SAPEC SA with R&D and production of reduced folates for pharmaceutical use, today, the Chemical Division of CERBIOS has over 30 years of expertise in industrial scale manufacturing of APIs and over 10 years of expertise in the manufacture of High Potency Active Ingredients (HPAIs) requiring production units with high containment levels.
Over the years, the skills of the Chemical Division have turned CERBIOS into a leading company in the field of Reduced Folates. These compounds which are mainly used in the therapy of colon and rectal cancer as well as in the prevention and treatment of vitamin deficiencies are sold to pharma companies world-wide, mainly in the highly regulated markets including EU, USA and Japan.
In addition, more than 10 years ago, the Chemical Division started with the development and manufacturing of vitamin D derivatives (HPAIs). During the last few years, Cerbios has made substantial investments in infrastructure to strengthen and extend its activities and services in the area of HPAIs .
Using its comprehensive know how and expertise, in the past years the Chemical Division has started to offer contract manufacturing services in the area of HPAIs including full CMC assistance (technology transfer, chemical process development and scale up, analytical development and validation, manufacture of clinical, registration/validation batches and commercial supply). A professional regulatory support from our team is paramount to all activities.